Grant-writing for Implementation Sciences Research

1. Grant-writing for Implementation Sciences Research • Mary Beth Weber • K.M. Venkat Narayan • Emory Global Diabetes Research Center

2. Translational research transforms currently available knowledge into useful measures for everyday clinical and public health practice. Translational research aims to assess implementation of standards of care, understand the barriers to their implementation, and intervene throughout all levels of health care delivery and public health to improve quality of care and health outcomes, including quality of life. Narayan et al. Ann Intern Med, 2004

3. DISTRIBUTION AVAILABILITY EFFICIENCY EFFECTIVENESS EFFICACY FUNDAMENTAL RESEARCH DETSKY, 1990

4. Presentation overview • Study aims and objectives • Background • Research plan • Sustainability • Budget

5. 1. Study Aims and Objectives

6. Aims and objectives Aim: To evaluate the effectiveness, cost-effectiveness, and sustainability of a community-based diabetes prevention program in Chennai, India using a randomized controlled trial, with 700 people with pre-diabetes randomized to either standard lifestyle advice or a culturally specific, low-cost, intensive lifestyle intervention • Objective 1: To evaluate effectiveness of the lifestyle intervention by assessing between group changes in the following: • Primary Outcome: incidence of T2DM • Secondary Outcomes: body weight, percent body fat, body mass index, waist-to-hip ratio, fasting glucose, blood pressure, plasma lipids, activity, and diet

7. Aim: To evaluate the effectiveness, cost-effectiveness, and sustainability of a community-based diabetes prevention program in Chennai, India using a randomized controlled trial, with 700 people with pre-diabetes randomized to either standard lifestyle advice or a culturally specific, low-cost, intensive lifestyle intervention • Objective 1: To evaluate effectiveness of the lifestyle intervention by assessing between group changes in the following: • Primary Outcome: incidence of T2DM • Secondary Outcomes: body weight, percent body fat, body mass index, waist-to-hip ratio, fasting glucose, blood pressure, plasma lipids, activity, and diet Aim: Clearly states the point of the study, including important details about the research. The aim can also be stated as a question or as a hypothesis.

8. Aim: To evaluate theeffectiveness, cost-effectiveness, and sustainabilityof a community-based diabetes prevention program in Chennai, India using a randomized controlled trial, with 700 people with pre-diabetes randomized to either standard lifestyle advice or a culturally specific, low-cost, intensive lifestyle intervention • Objective 1: To evaluate effectiveness of the lifestyle intervention by assessing between group changes in the following: • Primary Outcome: incidence of T2DM • Secondary Outcomes: body weight, percent body fat, body mass index, waist-to-hip ratio, fasting glucose, blood pressure, plasma lipids, activity, and diet

9. Aim: To evaluate the effectiveness, cost-effectiveness, and sustainability of a community-based diabetes prevention program in Chennai, India using arandomized controlled trial, with 700 people with pre-diabetes randomized to either standard lifestyle advice or a culturally specific, low-cost, intensive lifestyle intervention • Objective 1: To evaluate effectiveness of the lifestyle intervention by assessing between group changes in the following: • Primary Outcome: incidence of T2DM • Secondary Outcomes: body weight, percent body fat, body mass index, waist-to-hip ratio, fasting glucose, blood pressure, plasma lipids, activity, and diet

10. Aim: To evaluate the effectiveness, cost-effectiveness, and sustainability of a community-based diabetes prevention program in Chennai, India using arandomized controlled trial, with 700 people with pre-diabetes randomized to either standard lifestyle advice or a culturally specific, low-cost, intensive lifestyle intervention • Objective 1: To evaluate effectiveness of the lifestyle intervention by assessing between group changes in the following: • Primary Outcome: incidence of T2DM • Secondary Outcomes: body weight, percent body fat, body mass index, waist-to-hip ratio, fasting glucose, blood pressure, plasma lipids, activity, and diet

11. Aim: To evaluate the effectiveness, cost-effectiveness, and sustainability of a community-based diabetes prevention program in Chennai, India using a randomized controlled trial, with 700 people with pre-diabetes randomized to either standard lifestyle advice or a culturally specific, low-cost, intensive lifestyle intervention • Objective 1: To evaluate effectiveness of the lifestyle intervention by assessing between group changes in the following: • Primary Outcome: incidence of T2DM • Secondary Outcomes: body weight, percent body fat, body mass index, waist-to-hip ratio, fasting glucose, blood pressure, plasma lipids, activity, and diet

12. Aim: To evaluate the effectiveness, cost-effectiveness, and sustainability of a community-based diabetes prevention program in Chennai, India using a randomized controlled trial, with 700 people with pre-diabetes randomized to either standard lifestyle advice or a culturally specific, low-cost, intensive lifestyle intervention • Objective 1: To evaluate effectiveness of the lifestyle intervention by assessing between group changes in the following: • Primary Outcome: incidence of T2DM • Secondary Outcomes: body weight, percent body fat, body mass index, waist-to-hip ratio, fasting glucose, blood pressure, plasma lipids, activity, and diet Objective: Describes how the investigators will answer the research question

13. Aims and objectives • Aim 1: Can peer education and support groups be used to influence lifestyle choices and prevent obesity in men living in Karachi?

14. Aim example • Aim 1: Can peer education and support groups be used to influence lifestyle choices and prevent obesity in men living in Karachi? • Problems: • Study design? • Lifestyle choice outcome is vague

15. Aims and objectives: General information • Begin by summarizing the need for this research • Clearly state your main research objective in the form of aims or a hypothesis • Briefly describe how you are going to do the project in objectives or a paragraph • Length: 1-2 pages

16. Aims and objectives: General information • After reading your aims section, the reader should be able to: • State the need for your project • Agree that the project is needed • Summarize the main purpose and broad methods of your project • Be excited and interested to read the rest of your proposal

17. Questions and discussion

18. 2. Background

19. Background • Summarize pertinent literature • The problem your project is addressing • Other studies addressing this problem • Highlight what is missing in the literature • The research that you are translating • Support for the theories and methods that you are using • End with a clear summary • Preliminary research • Length: 1-2 pages

20. Background • Your background sections should be: • Thorough but succinct • Well-written • Easy to read and follow • Subheadings • Pertinent

21. Questions and discussion

22. 3. Research Plan

23. Study design Outcomes Study testing Study Sample Timeline Intervention Power and data analysis plan Key personnel Ethical Issues Research plan components

24. Study design Outcomes Study testing Study Sample Timeline Intervention Data analysis plan Key personnel Ethical Issues Research plan components

25. How to select the best study design • Study design • Should be closely linked to the purpose of the evaluation • Should build on a theoretical framework of behavioral change or other relevant strategy • Should consider randomized designs first • Non-randomized designs or designs where the unit of randomization is other than the participant may be the most appropriate for implementation research questions

26. Study design selection • Challenge in implementation research is that the interventions are usually complex (multifaceted with simultaneous changes in different parts of the organization) • Researcher has variable control over how the intervention is implemented Eccles M, et al. Qual Saf Health Care 2003;12;47-52

27. Critical steps in the research plan before the definitive study • Development of a theoretical basis for the intervention • Define the components of the intervention • Exploratory studies of observational data + qualitative research to further refine the intervention and planned evaluation • Definitive evaluation Eccles M, et al. Qual Saf Health Care 2003;12;47-52

28. Types of studies Quantitative non-experimental designs Quantitative experimental designs Randomization Qualitative Multi-level, multi-factorial interventions Community-based participatory research

29. Quantitative non-experimental designs • Cross-sectional designs • Uncontrolled before and after (longitudinal observational cohort studies) • Controlled before and after • Time series analyses • In translational research there can be political, practical, and ethical barriers to randomized designs – but randomized designs should first be considered

30. Types of intervention studies • Randomized or quasi-randomized trials • Interrupted time series (ITS) • Defined intervention • 3 points in time before and after • Non-randomized studies with controls at a second site • Data collected before and after the intervention • Key to interpretation hinges on comparability of the sites • Most are evaluations within systems rather than between systems

31. Quantitative experimental designs • Individual patient-level randomized controlled trials • Cluster randomized controlled trials • Strongest designs to establish a causal relationship • Often times difficult to implement…but considering them is important

32. Randomized controlled trials • Considered to be the gold standard • Randomly allocated to either intervention or control group • Best way to insure that both known and unknown factors that may influence effectiveness of the intervention are balanced in the two comparison groups • Time consuming, expensive, complex, may require a large number of clusters, tight inclusion criteria limit generalizabilty • May not tell you whether an intervention will improve routine practice

33. Level of randomization • Patient • Health care professional • Practice/hospital • Provider group • Health plan • Community LOW LEVEL CONTAMINATION HIGH LEVEL POWER, LOGISTICS

34. Level of randomization • At higher levels of randomization measure-ment of pre-intervention characteristics is critically important • Consider stratification on baseline characteristics that are likely to influence the effectiveness of the intervention • Cluster randomization is likely to violate the assumption of independence of observations within a cluster • Two patients in same practice are likely to be more similar than three from different practices • Need to be able to estimate the intracluster correlation coefficient (ICC)

35. Cluster randomization • Many quality improvement (QI) interventions are at provider or system level and if you randomize at individual patient level it is likely there will be contamination • Randomization at higher level will reduce contamination but you pay a high price with regard to power and ability to detect clinically meaningful differences in outcomes; additionally, risk for bias is much higher • Randomize at a higher level but collect data at the patient level

36. Analysis of cluster randomization • Analysis at cluster level uses the cluster as unit of randomization and unit of analysis • Each cluster is treated as one data point (inefficient!) • Patient level analyses that are adjusted for the cluster • Patient level analyses that allow for correlation between clusters is explicitly modeled; hierarchical nature of data is accounted for in the analysis • Unit of randomization must be accounted for in all analyses

37. Qualitative studies • Results from qualitative studies can provide critical information in the translation of interventions to real world settings that have been shown to be effective in clinical trials • Meanings, definitions, and characteristics of phenomenon • Increase acceptability, cultural appropriateness, and feasibility • Relying on current literature may not be sufficient

38. Types of qualitative research • Direct observation • Observe but do not interact

39. Types of qualitative research • Direct observation • Written documents

40. Types of qualitative research • Direct observation • Written documents • In-depth interviews • Individual interviews • Focus group discussions

41. Questions to ask before including qualitative research in your study • Is qualitative research the best way to answer your research question? • Is the methodology appropriate to the research question? • Justify your research method

42. Mixed Methods Studies • “Quantitative research excels at summarizing large amounts of data and reaching generalizations based on statistical perceptions. Qualitative research excels at “telling the story” from the participant’s viewpoint, providing the rich descriptive detail that sets quantitative results into their human context.” Trochim, W.M.K., Research Methods Knowledge Base: www.socialresearchmethods.net

43. Background premises for multi-level, multi-factorial interventions • We live in contexts: patients, families, providers, clinics, health systems, societies • Behavior change and quality improvement are difficult • Multiple interventions are more effective than single • Diabetes and obesity are chronic conditions: chronic care / chronic disease models

44. Community-based participatory research • Community focus: often vulnerable or hard to reach populations • Collaboration: community and academic partners • Equal relationships • Benefit of community • Ultimately interventions • Reduce disparities

45. Study design Outcomes Study testing Study Sample Timeline Intervention Data analysis plan Key personnel Ethical Issues Research plan components

46. Study outcomes • One primary outcome • One or more secondary outcomes • Short-term, intermediate, and long-term outcomes

47. Aim: To evaluate the effectiveness, cost-effectiveness, and sustainability of a community-based diabetes prevention program in Chennai, India using a randomized controlled trial, with 700 people with pre-diabetes randomized to either standard lifestyle advice or a culturally specific, low-cost, intensive lifestyle intervention • Objective 1: To evaluate effectiveness of the lifestyle intervention by assessing between group changes in the following: • Primary Outcome: incidence of T2DM • Secondary Outcomes: body weight, percent body fat, body mass index, waist-to-hip ratio, fasting glucose, blood pressure, plasma lipids, activity, and diet

48. Immediate Outcomes Intermediate Outcomes Learning Knowledge Skill Acquisition Post-Intermediate Outcomes Behavior Change Long Term Outcomes Improved Clinical Indicators Improved Health Status Health care outcomes continuum

49. Study outcomes • Can be quantitative or qualitative in nature • Should be sensible based on study design and research question • Should be practical

50. What is practical? • Reliable and valid • Succinct and/or engaging • Relevant to setting and question • Broadly applicable: literacy, culture, language • Reasonable burden on the study participants